Multi-level Approach of Brain Activity Using Intracranial Electrodes in Epileptic Patients (EpiMicro)

Institut National de la Santé Et de la Recherche Médicale, France

Status: Enrolling

Conditions: Cognitive Function; Neurophysiology; Focal Epilepsy; Electrodes, Implanted

Treatments: Device: Intracranial macro-microelectrode recording

Study type: Interventional

Funder types: Other

Identifiers

NCT04653012

2020-A00445-34 (Registry Identifier)

C19-55

Details and patient eligibility

About

The main goal of this project is to study the mechanisms of epileptic activities using intracranial macro and micro electrodes in epileptic patients undergoing pre-surgical investigation.

The recordings will also be used to study physiological mechanisms like sleep and different cognitive functions.

Enrollment: 50 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients with focal drug-resistant epilepsy
• Patients who undergo a presurgical evaluation with intracranial electrodes in the videoEEG unit of the Neurology department at the Pitié-Salpêtrière hospital.
• Patients who have been informed and provided written informed consent to take part in the study

Exclusion criteria

• Contraindication for an intracranial investigation (with macro-electrodes) : intercurrent infectious syndrome, decompensated associated pathology (cardiac, pulmonary, renal, hepatic), patient with increased risk of infection (ex: under immunosuppressive therapy)
• Pregnant or parturient woman
• Breastfeeding woman
• Minor person or legally protected adult (tutelage, legal guardianship, maintenance of justice)

Trial design

Primary purpose: Basic Science

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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50 participants in 1 patient group

Macro-microelectrode implantation

Experimental group

Description:

Implantation of macro-micro electrodes of the Adtech Benkhe-Fried type in epileptic patients who are undergoing evaluation with intracranial EEG electrodes

Treatment:

Device: Intracranial macro-microelectrode recording